Inogen at Home Stationary Concentrator
Inogen At Home is a stationary oxygen concentrator for prescribed supplemental oxygen in a home or institution. It delivers continuous flow from 1 to 5 L/min in 1 L/min steps, with oxygen…
Inogen At Home is a stationary oxygen concentrator for prescribed supplemental oxygen in a home or institution. It delivers continuous flow from 1 to 5 L/min in 1 L/min steps, with oxygen supplied to the patient through a nasal cannula.
Pressure-swing adsorption separates oxygen from ambient air. Molecular sieve beds preferentially capture nitrogen under pressure, then release it as the pressure falls, while enriched oxygen collects in an accumulator.
Listed Item
Inogen At Home Stationary Concentrator, NCE (10-05345-XX-XX)
Power and Control
The concentrator operates from mains AC power through a detachable cord. Valves, sensors and embedded software govern the alternating sieve-bed process for continuous use.
Who Else Makes It
Concentrated in Jiangsu (6), Guangdong (5), Beijing (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Foshan Kycare Medical Equipment Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 3 |
| Jakamed Instruments Co., Ltd. | Changsha | Hunan | Contract manufacturer | 2 |
| Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 37 |
| Beijing Choice Electronic Technololgy Co., Ltd. | Beijing | Beijing | Repacker / relabeller | 30 |
| Jiangsu Yuyue Medical Equipment & Supply Company Limited | Jiangsu | Jiangsu | Contract manufacturer | 17 |
| Tianjin Choice Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 12 |
| Danyang Huayi Medical Supply & Equipment Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 11 |
| Shandong Moonlight Electronics Tech Co., Ltd. | Weifang | Shandong | Manufacturer | 11 |
| Honsun (Nantong) Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 9 |
| Beijing Choicemmed Technology Co., Ltd. | Beijing | Beijing | Repacker / relabeller | 9 |
| Foshan Care Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 3 |
| Zhengzhou Olive Electronic Technology Co., Ltd. | Zhengzhou | Henan | Manufacturer | 3 |
Showing 12 of 22. All 22 manufacturers in China registered for Generator, Oxygen, Portable
Record
| Listed by | Inogen, Inc., United States |
|---|---|
| FDA product code | CAW |
| Device type | Generator, Oxygen, Portable |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5440 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K132489 |
| Record published | 2017-03-27 |
| Record revised | 2025-06-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Handling environment humidity 15 to 95 % RH; Handling environment temperature 41 to 104 °F; Storage environment humidity 0 to 93 % RH; Storage environment temperature -13 to 158 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CE | In distribution | |
| NCE | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeVilbiss | DeVilbiss Healthcare LLC. | 50 |
| EverFlo | Respironics Inc. | 32 |
| Mark 5 Nuvo Lite | Nidek Medical Products, Inc. | 30 |
| SimplyGo Mini | Respironics Inc. | 26 |
| X-PLO2R | Belluscura, LLC | 17 |
| Mark 5 Nuvo 8 | Nidek Medical Products, Inc. | 12 |
| ViveBreathe | Vive Health LLC | 11 |
| Invacare® HomeFill® Oxygen System | Invacare GmbH | 11 |
| Discov-R | Belluscura, LLC | 11 |
| NewLife Elite | Caire Inc. | 10 |
| NewLife Elite | Airsep Corp. | 10 |
| Rhythm Healthcare | Qingdao Kingon Medical Science AND Technology Co., Ltd. | 9 |
Showing 12 of 187. All products under Generator, Oxygen, Portable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K230052 | 2023-06-30 |
| K222086 | 2022-12-09 |
| K132489 | 2014-06-20 |
| K032818 | 2004-05-13 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2005-08-01 | Not classified | Other | Firm plans to upgrade all units to correct situations that could lead to interuption in oxygen delivery. | 900 | 2007-02-13 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.